Study Description: A Phase I/IIA Study To Assess Safety. Tolerability and Preliminary Activity of the Combination of FAK (Defactinib) and PD‐1 (Pembrolizumab) Inhibition in Patients with Advanced Solid Malignancies
Study Design: Phase I dose escalation trial for 'all‐comers' followed by expansion cohorst at the optimal doses in patients with (a) pancreatic cancer; (b) NSCLC; and (c) mesothelioma
Primary Endpoint:
- Adverse Events (AEs) using CTCAE v4.03, does limiting toxicity (DLT) and maximum tolerated dose (MTD) assessment
Secondary Endpoint:
- Objective response rate (ORR), using best objective response by irRECIST
- Duration of response (DoR)
- Progression free survival (PFS), using irRECIST
- Overall survival
- Change in FAK Y937 phosphorylation
- Change in immune call infiltrate
Trial Status: In set up
Chief Investigator: Dr Stefan Symeonides, University of Edinburgh, Western General Hospital, Edinburgh
Sponsor: University of Glasgow/NHS Greater Glasgow & Clyde
Date Opened: In set up
Planned Closure Date: TBC
Target Recruitment: 12 patients in Phase I/47 patients in Phase II
Open to New Sites: In set up
Contact Details:
Clinical Trials Unit, Glasgow (CTUG)
Project Manager: Lorna Sweeting [email protected]
Clinical Trial Co-ordinator: Susan Dillon [email protected]
Tel: 00 44 (0) 141 301 7194 / 00 44 (0) 141 301 7232
Cancer Research UK Clinical Trials Unit,
Beatson West of Scotland Cancer Centre,
1053 Great Western Road, Glasgow, G12 0YN
Fax: 00 44 (0) 141 301 7946
Click here to download the Initiation Slides
For queries concerning Pharmacovigilance, or the documents to refer to for the clinical management of trial patients or those that are acting as the Reference Safety Information please contact:
The Pharmacovigilance Team email: [email protected] or
Telephone: 0141 211 0352/0203/3567/3968 or 0141 232 2068
Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) being used for the study (if applicable): 4.03
Click here to download the CTCAE
